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Exactech® Truliant™ Line Extensions

by Exactech, Inc.

510(k) K171045

Exactech® Truliant™ Line Extensions is a Class II device made by Exactech, Inc., cleared under FDA 510(k) K171045 on 28 Apr 2017, active as of 26 Oct 2026. 2 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source FDA 510(k), synced 26 Oct 2026.

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK171045 Date28 Apr 2017ClearedStatusActive

Official records

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-0585-2024 FDA Class II initiated 21 Nov 2023

    Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

    • Ongoing Z-0023-2022 FDA Class II initiated 30 Aug 2021

    Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

Timeline

3 dated events

  1. Cleared FDA 510(k) K171045
  2. Recall initiated FDA recalls Z-0023-2022
  3. Recall initiated FDA recalls Z-0585-2024

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
JWH
Device class
Class II
Regulation
21 CFR Part 888.3560
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

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